July 7, 2014 — Affymax will pay $6.5 million to settle a class action lawsuit that was filed by investors who accused the drug-maker of misleading them about the risks of Omontys (pedinesatide).
Omontys is an anemia drug that helps stimulate bone marrow to produce more red blood cells. It was a once-monthly injectable drug that was the first FDA-approved erthyropoiesis-stimulating agent for dialysis patients with anemia.
Unfortunately, it was linked to severe hypersensitivity reactions and pulled off the market in February 2013. These reactions included anaphylaxis, which is a whole-body immune system response to chemicals that are identified as allergens. Anaphylaxis can cause tissues in the airway to swell, causing suffocation.
By the time Omontys was recalled, about 25,000 people had used Omontys and the FDA had received 98 adverse event reports, including 12 deaths. Although the side effect was relatively rate, many events were very serious:
“The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.”
Takeda Pharmaceuticals investigated the adverse events and concluded that they were not caused by problems with manufacturing or quality-control. Takeda and Affymax have terminated their collaboration on Omontys and asked the FDA to withdraw approval. Because Omontys was Affymax’s only drug, this month the board of directors decided to liquidate the company.
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